510(k) K160308
- Device
- Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
- Applicant
- Fudakang Industrial Co., Ltd
- 510(k) number
- K160308
- Product code
- FLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-15
- Date received
- 2016-02-04
- Regulation
- 880.2910
- Classification name
- Thermometer, Electronic, Clinical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bob Yu
- Address
- # 8 Yinghe Rd., Yuanjiangyuan Management Zone, Changping Town Dongguan CN 523560 523560
FDA Registration Numbers#
- 3008048783
- 3005785090
- 3008956776
- 3005798905
- 3012302888
- 3004727197
- 3008729899
- 3011182134
- 2184009
- 3001570235
- 3037341611
- 3009499478
- 3011167030
- 3006169981
- 3003263092
- 3005031124
- 3014468707
- 3010419931
- 3003591740
- 3016904853
- 1220908
- 3017581269
- 2081040
- 3012804266
- 3008058135
- 3011835632
- 3008771621
- 3037007069
- 3032109
- 3009685433
- 3021559257
- 1054241
- 3009888765
- 3006537699
- 3008716327
- 9710548
- 3021186226
- 1018233
- 3004832480
- 3017887928
- 8010026
- 3003887292
- 3023031046
- 3006610790
- 3005841768
- 3008507279
- 3010521050
- 3010041511
- 3011077581
- 3009831876
- 3042156936
- 2025816
- 2082313
- 3015542362
- 3027605322
- 3009756153
- 3014848734
- 3010713600
- 3012421607
- 3013826848
- 1250045
- 3005905524
- 3007134734
- 3013596024
- 3038613041
- 3015455735
- 9616843
- 8043323
- 3015276780
- 3007838093
- 2030624
- 8031509
- 3029871637
- 3012725363
- 3015136472
- 9615140
- 3019388613
- 3022028624
- 3009308092
- 3004111573
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | 2026-06-05 |
| K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026-01-08 |
| K250470 | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 |
| K243000 | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-05-22 |
| K243082 | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | 2025-04-25 |
| K250401 | AION TempShield™ | Aion Biosystems, Inc. | 2025-03-14 |
| K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | 2025-02-14 |
| K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024-10-30 |
| K240223 | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 |
| K240220 | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2024-09-27 |
| K240077 | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | 2024-08-20 |
| K233280 | SteadyTemp | Steadysense GmbH | 2024-06-21 |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | 2024-06-05 |
| K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024-04-12 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases